Amlodipine Besylate And Olmesartran Medoxomil

1 INDICATIONS AND USAGE Amlodipine and olmesartan medoxomil tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine and olmesartan medoxomil tablets.

6 ADVERSE REACTIONS Most common adverse reaction (incidence ≥3%) is edema ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Amlodipine and Olmesartan Medoxomil Tablets The data described below reflect exposure to amlodipine and olmesartan medoxomil tablets in more than 1600 patients including more than 1000 exposed for at least 6 months and more than 700 exposed for 1 year.

8.1 Pregnancy Risk Summary Amlodipine and olmesartan medoxomil tablets can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death [see Clinical Considerations]. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents.

WARNING: FETAL TOXICITY When pregnancy is detected, discontinue amlodipine and olmesartan medoxomil tablets as soon as possible (5.1, 8.1). Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death to the developing fetus (5.1, 8.1). WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue amlodipine and olmesartan medoxomil tablets as soon as possible ( 5.1 , 8.1 ). 5 WARNINGS AND PRECAUTIONS • Anticipate hypotension in volume-or salt-depleted patients with treatment initiation. Start treatment under close supervision ( 5.2 ). • Increased angina or myocardial infarction may occur upon dosage initiation or increase ( 5.3 ). • Impaired renal function: changes in renal function occur ( 5.4 ). • Sprue-like enteropathy has been reported. Consider discontinuation of amlodipine and olmesartan medoxomil tablets in cases where no other etiology is found ( 5.6 ). 5.1 Fetal Toxicity Amlodipine and olmesartan medoxomil tablets can cause fetal harm when administered to a pregnant woman. 4 CONTRAINDICATIONS Do not co-administer aliskiren with amlodipine and olmesartan medoxomil tablets in patients with diabetes [ s ee Drug Interactions ( 7.2 ) ] . Do not co-administer aliskiren with amlodipine and olmesartan medoxomil tablets in patients with diabetes ( 4 ).